Understanding and mitigating impact of immunogenicity on pharmacokinetic assays-Reference-Cited by-同舟云学术

Understanding and mitigating impact of immunogenicity on pharmacokinetic assays

Published:2011-08 Issue:16 Volume:3 Page:1799-1803
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

White Joleen T¹,Golob Michaela²,Sailstad Jeffrey³

Affiliation:

1. Biogen Idec, 14 Cambridge Center, Cambridge, MA 02142

2. Merck Serono, MS-RD DMPK/rADME, Haidling 17, D-85567 Grafing, Germany

3. Sailstad & Associates Inc., 6 Porchlight Court, Durham, NC 27707, USA.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

http://www.future-science.com/doi/pdf/10.4155/bio.11.162

Reference6 articles.

1. Detection of antibodies against therapeutic proteins in the presence of residual therapeutic protein using a solid-phase extraction with acid dissociation (SPEAD) sample treatment prior to ELISA

2. Immune Responses to Therapeutic Proteins in Humans - Clinical Significance, Assessment and Prediction

3. US Department of Health and Human Services, Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for Industry Bioanalytical Method Validation, May 2001.

4. Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules

5. Therapeutic Immunogenicity Focus Group of the American Association of Pharmaceutical Scientists.www.aaps.org/inside/focus_groups/TherPro/index.asp(Accessed June 2011).

Cited by 17 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Interference from anti-drug antibodies on the quantification of insulin: a comparison of an LC-MS/MS assay and immunoassays;Bioanalysis;2024-09-12

2. 2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A – Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine);Bioanalysis;2022-05

3. High ionic strength dissociation assay (HISDA) for high drug tolerant immunogenicity testing;Bioanalysis;2020-06-30

4. Generic Peptide Strategies for LC-MS/MS Bioanalysis of Human Monoclonal Antibody Drugs and Drug Candidates;Protein Analysis using Mass Spectrometry;2017-06-02

5. Immunogenicity and its effect on pharmacokinetics of biotherapeutics;Current Issues in Ligand Binding Assay Bioanalysis;2016-03